510(k) K833047— DOSIMETRIC RELEASE OF RAD. TUBING PAC

Substantially Equivalent

American Bentley

Clearance details

Applicant: American Bentley
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1983-09-06
Decision date: 1985-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.